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CTRI Number  CTRI/2025/10/096615 [Registered on: 29/10/2025] Trial Registered Prospectively
Last Modified On: 20/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study comparing the pharmacokinetics of various Urolithin A (Mitopure) formulations in healthy adults. 
Scientific Title of Study   Comparative pharmacokinetics of Urolithin A (Mitopure) formulations in healthy adults: a randomized, open-label, single-dose, parallel-arm study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/25-26/017 Version: 1.00; Dated, 13 September 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ram Mundhe 
Designation  Principal Investigator 
Affiliation  Gunjkar Multispeciality Hospital 
Address  OPD/room no 2 Ground floor Spine Road Shivtej nagar chinchwad
-
Pune
MAHARASHTRA
411019
India 
Phone  8454859082  
Fax  -  
Email  drrammudhe.gunjkarresearch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayatri Ganu  
Designation  Managing Director 
Affiliation  Mprex Healthcare Pvt. Ltd. 
Address  8th Floor office no 813- 816 sai millenium punawale Pune
-
Pune
MAHARASHTRA
411033
India 
Phone  8554912644  
Fax  -  
Email  drgayatri@mprex.in  
 
Details of Contact Person
Public Query  
Name  Dr Gayatri Ganu  
Designation  Managing Director 
Affiliation  Mprex Healthcare Pvt. Ltd. 
Address  8th Floor office no 813- 816 sai millenium punawale Pune
-
Pune
MAHARASHTRA
411033
India 
Phone  8554912644  
Fax  -  
Email  drgayatri@mprex.in  
 
Source of Monetary or Material Support  
Amazentis SA EPFL Innovation Park, Bâtiment C 1015 Lausanne Switzerland. 
 
Primary Sponsor  
Name  Amazentis SA 
Address  EPFL Innovation Park, Bâtiment C 1015 Lausanne Switzerland. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ram Mundhe  Gunjkar Multispeciality Hospital  OPD no 2 Ground floor Spine Road Shivtej nagar chinchwad
Pune
MAHARASHTRA 		 08454859082
-
drrammudhe.gunjkarresearch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sangvi Multispecialty Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Adults  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Formulation A: Mitopure- Urolithin A vegan softgel capsules (UA-VeganSG)   Two capsules, delivering a total dose of 500 mg of Urolithin A (each capsule containing 250 mg). single dose only  
Intervention  formulation B: Mitopure- Urolithin A hard capsule(Q32939)  One capsule, delivering a total dose of 500 mg of Urolithin A single dose Only  
Intervention  Formulation C: Mitopure- Urolithin A spray dried with Arabic gum vegan hard capsules (VC-UASDAG)  Two capsules, delivering a total dose of 500 mg of Urolithin A (each capsule containing 250 mg) Single dose only  
Intervention  Formulation D: Mitopure- Urolithin A spray dried with Arabic gum powder (UA-SDAG)  650 mg powder delivering a total dose of 500 mg of Urolithin A single dose only 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Healthy male and female participants aged between 18 and 45 years (both inclusive);
2. Non-smoker subject or smoker of not more than 5 cigarettes a day;
3. Body Mass Index (BMI) between 18.50-30.00 kg per m2 inclusive;
4. Trial participants in normal health as determined by personal medical history, clinical examination including vital signs,and clinically acceptable results of laboratory examinations (including serological tests), individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator;
5. Normal electrocardiogram (ECG) recording on a 12-lead ECG and/or chest X-ray (PA view) significant at the screening visit or considered not clinically significant (NCS) by investigators;
6. A negative alcohol breath test result at housing;
7. Trial participant able to communicate effectively, provide voluntary written informed consent and available for the entire study duration;
8. Trial participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee
9. Ability to fast for at least 14.00 hours and consume standard meals;
10. Accept to refrain consuming certain foods and supplements at least two weeks before inclusion;
11. Female participants must have a negative urine pregnancy test prior to housing;
12. Trial participants that can provide adequate evidence of their identity;
13. The participants agree to refrain from consuming dietary supplements that could potentially impact either muscle or mitochondrial function or contain Urolithin A, such as resveratrol, pomegranate and ellagitannins, nicotinamide riboside, whey protein, leucine, iso-leucine, l-carnitine,creatinine, coenzyme Q10, vitamin A, niacin, folic acids,vitamin C, vitamin E and probiotic foods and supplements, during the 2 weeks before inclusion and throughout the study;
14. Females of childbearing potential agree to use appropriate contraceptive measures like non-hormonal intrauterine devices, barrier methods, and spermicidal agents during the study and 07 days after completion of the study;
15. Male agreeing to use appropriate contraceptive measures like the Double Barrier method (Condom), and should not donate sperm, etc. during the study and 07 days after completion of the study. 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to Urolithin A or related product or any component of intervention, presence or history of drug hypersensitivity, allergic disease or lactose intolerance;
2. Any history or presence of clinically significant medical condition, such as, but not limited to, cardiovascular,pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease, thyroid disease, adrenal dysfunction, or organic intracranial lesion;
3. Any treatment which could bring about induction or inhibition of the hepatic microsomal enzyme system within one month of starting the study;
4. History or presence of alcoholism or drug abuse;
5. History or presence of gastric and/or duodenal ulceration;
6. History or presence of cancer;
7. Difficulty with donating blood;
8. Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week before study initiation and throughout the study;
9. Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study
10. Trial participant consumed tobacco/tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48.00 hours before initiation of the study and throughout the study;
11. Trial participant consumed caffeine and/or xanthine containing foods or beverages (i.e., coffee, tea, chocolate,and caffeine-containing sodas, colas, etc.) and grapefruit juice and poppy-containing foods for at least 48.00 hours before initiation of the study and throughout the study;
12. Major illness during the 90 days before screening;
13. Participation in a drug research study within 90 days of screening;
14. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL;
15. History or presence of easy bruising or bleeding;
16. Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study;
17. Females of childbearing potential with any one of the
following reported and documented on the medical history:
i. Postmenopausal with spontaneous amenorrhea for at least one year, or
ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
iii. Total hysterectomy and an absence of bleeding for at least 3 months;
iv. Female volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 07 days before dosing;
18. Pregnant women and nursing mothers;
19. Male and females of childbearing potential unwilling to employ appropriate and reliable method of contraception like non-hormonal intrauterine devices, barrier methods, and spermicidal agents, Double Barrier method (Condom) during the study till 07 days after the completion of the study;
20. Male volunteers willing to donate sperm during the study till 07 days after the completion of the study.
21. Allergy to peanuts, nuts, pea, or gum guar. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Plasma Pharmacokinetics parameters of all four Urolithin A Formulations   PK blood samples will be collected at pre-dose [within 45 min before IP administration] and post-dose at 1hr, 4hrs, 6hrs, 8hrs,12hrs, 24hrs, 72hrs. (Total 8 Time points) 
 
Secondary Outcome  
Outcome  TimePoints 
1. vital signs.
2. Chest X-ray ((P/A view)
3. Clinical examination, ECGs, and clinical laboratory testing (hematology, blood chemistry, and urinalysis)
4. Adverse events, serious adverse events
5. Tolerability of the investigational product  		 1. at Screening, pre-dose, and post-dose
2. at screening.
3. at screening and end of the study.
4. throughout the study.
5. from administration to end of the study.


 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/11/2025 
Date of Study Completion (India) 28/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary    Functional food and food supplements that have been precisely calibrated to deliver bioactive natural ingredients are a desirable way to unlock health benefits to a wider target population, i.e., those unable to derive the benefits of dietary components that impart various health promoting benefits. Amazentis has developed a food supplement and food product that contains MITOPURE (UA) at specific levels after a controlled manufacturing process such as softgel capsules, hard capsuels and powder. In the case of MITOPURE, which is a metabolite of a natural product present in food, one can only guarantee precise dosing levels by providing the bioactives in a specific formulation. Practically, it would not be possible to consume food products and receive the similar benefits of MITOPURE due to (1) seasonality (2) content level and (3) interpersonal variations of metabolism. 
 This clinical trial aims to comprehensively evaluate and compare the pharmacokinetic profiles of four distinct formulations of Urolithin A in healthy volunteers. Urolithin A, a metabolite derived from ellagic acid in foods, has garnered attention for its potential health benefits, including its association with improved muscle recovery and antioxidant properties. The formulations under investigation include a Formulation A: vegan softgel capsule (Mitopure Urolithin A) (UA-VeganSG), formulation B: Mitopure- Urolithin A hard capsule (Q32939), formulation C: Mitopure- Urolithin A spray dried with Arabic gum vegan hard capsules (VC UASDAG) and formulation D: Mitopure- Urolithin A spray dried with Arabic gum powder (UA-SDAG). 
 The study adopts a randomized, open-label, single-dose, parallel-arm approach. The primary objective is to elucidate and compare the plasma pharmacokinetic parameters across the four Urolithin A formulations. By employing a rigorous methodology involving pharmacokinetic sampling at predetermined time points, this trial aims to provide detailed insights into the absorption, distribution, metabolism, and excretion of Urolithin A. Safety considerations are paramount, with secondary objectives focusing on assessing the safety and tolerability of the Urolithin A formulations. Adverse events and tolerability will be diligently monitored throughout the study, contributing to a comprehensive safety profile. 
 This study’s design as an open-label, single-dose, randomized trial aligns with the objective of characterizing the concentration-time profiles of Urolithin A formulation in a controlled setting. The inclusion criteria, stringent fasting requirements, standardized fluid intake and strict dietary restriction protocols ensure homogeneity among the study participants, enhancing the reliability of the outcomes
Ultimately, this clinical trial aims to contribute valuable insights into the pharmacokinetic behavior of different Urolithin A formulations, facilitating informed decisions for future developments and applications in the realm of health and wellness.
 
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